This invention relates to electrotherapy circuits and in particular to a defibrillator which is capable of applying damped biphasic defibrillation pulses to a patient.
Electro-chemical activity within a human heart normally causes the heart muscle fibers to contract and relax in a synchronized manner that results in the effective pumping of blood from the ventricles to the body""s vital organs. Sudden cardiac death is often caused by ventricular fibrillation (VF) in which abnormal electrical activity within the heart causes the individual muscle fibers to contract in an unsynchronized and chaotic way. The only effective treatment for VF is electrical defibrillation in which an electrical shock is applied to the heart to allow the heart""s electrochemical system to re-synchronize itself. Once organized electrical activity is restored, synchronized muscle contractions usually follow, leading to the restoration of cardiac rhythm.
FIG. 1 is an illustration of a defibrillator 10 being applied by a user 12 to resuscitate a patient 14 suffering from cardiac arrest. In cardiac arrest, otherwise known as sudden cardiac arrest, the patient is stricken with a life threatening interruption to their normal heart rhythm, typically in the form of ventricular fibrillation (VF) or ventricular tachycardia (VT) that is not accompanied by a palpable pulse (shockable VT). In VF, the normal rhythmic ventricular contractions are replaced by rapid, irregular twitching that results in ineffective and severely reduced pumping by the heart. If normal rhythm is not restored within a time frame commonly understood to be approximately 8 to 10 minutes, the patient 14 will die. Conversely, the quicker defibrillation can be applied after the onset of VF, the better the chances that the patient 14 will survive the event. The defibrillator 10 may be in the form of an automatic external defibrillator (AED) capable of being used by a first responder. The defibrillator 10 may also be in the form of a manual defibrillator for use by paramedics or other highly trained medical personnel.
A pair of electrodes 16 are applied across the chest of the patient 14 by the user 12 in order to acquire an ECG signal from the patient""s heart. The defibrillator 10 then analyzes the ECG signal to detect ventricular fibrillation (VF). If VF is detected, the defibrillator 10 signals the user 12 that a shock is advised. After detecting VF or other shockable rhythm, the user 12 then presses a shock button on the defibrillator 10 to deliver defibrillation pulse to resuscitate the patient 14.
The patient 14 has a transthoracic impedance (xe2x80x9cpatient impedancexe2x80x9d) that spans a range commonly understood to be 20 to 200 ohms. It is desirable that the defibrillator 10 provide an impedance-compensated defibrillation pulse that delivers a desired amount of energy to any patient across the range of patient impedances and with a peak current limited to safe levels substantially less than a maximum value.
The minimum amount of patient current and energy delivered that is required for effective defibrillation depends upon the particular shape of the defibrillation waveform, including its amplitude, duration, shape (such as sine, damped sine, square, exponential decay). The minimum amount of energy further depends on whether the current waveform has a single polarity (monophasic), both negative and positive polarities (biphasic) or multiple negative and positive polarities (multiphasic).
If the peak current of the defibrillation pulse that is delivered to the patient 14 exceeds the maximum value, damage to tissue and decreased efficacy of the defibrillation pulse will likely result. Peak current is the highest level of current that occurs during delivery of the defibrillation pulse. Limiting peak currents to less than the maximum value in the defibrillation pulse is desirable for both efficacy and patient safety.
Most external defibrillators use a single energy storage capacitor charged to a fixed voltage level resulting in a broad range of possible discharge times and tilt values of the defibrillation pulse across the range of patient impedances. A method of shaping the waveform of the defibrillation pulse in terms of duration and tilt is discussed in U.S. Pat. No. 5,607,454, xe2x80x9cElectrotherapy Method and Apparatusxe2x80x9d, issued Mar. 4, 1997 to Gliner et al. Using a single capacitor to provide the defibrillation pulse at adequate energy levels across the entire range of patient impedances can result in higher than necessary peak currents being delivered to patients with low patient impedances. At the same time, the charge voltage of the energy storage capacitor must be adequate to deliver a defibrillation pulse with the desired amount of energy to patients with high patient impedances.
Various prior art solutions to the problem of high peak currents exist using resistance placed in series with the patient 14 to compensate for variations in patient impedance. In U.S. Pat. No. 5,514,160, xe2x80x9cImplantable Defibrillator For Producing A Rectangular-Shaped Defibrillation Waveformxe2x80x9d, issued May 7, 1996, to Kroll et al., an implantable defibrillator having a rectilinear-shaped first phase uses a MOSFET operating as a variable resistor in series with the energy storage capacitor to limit the peak current. In U.S. Pat. No. 5,733,310, xe2x80x9cElectrotherapy Circuit and Method For Producing Therapeutic Discharge Waveform Immediately Following Sensing Pulsexe2x80x9d, issued Mar. 31, 1998, to Lopin et al., an electrotherapy circuit senses patient impedance and selects among a set of series resistors in series with the energy storage capacitor to create a sawtooth approximation to a rectilinear shape in the defibrillation pulse. Using current limiting resistors to limit peak current as taught by the prior art results in substantial amounts of power being dissipated in the resistors which increases the energy requirements on the defibrillator battery. Furthermore, such prior art circuits require complex, active control systems to regulate the current during the delivery of the defibrillation pulse.
The use of inductors in the energy storage circuit along with the energy storage capacitor to shape the defibrillation pulse is well known in the art. The basic RLC defibrillator topology is explained in U.S. Pat. No. 4,168,711, xe2x80x9cReversal Protection for RLC Defibrillatorxe2x80x9d, issued Sep. 25, 1979 to Cannon, III et al. RLC defibrillators utilize an inductor in series with the energy storage capacitor to deliver a damped sine wave defibrillation pulse. Such waveforms are typically not truncated and the discharge time is on the order of 50-60 milliseconds (ms). RLC defibrillator designs according to the prior art do not address the problem of limiting peak currents or otherwise compensating for the range of patient impedances.
More recent biphasic defibrillator designs such as the Heartstream Forerunner(copyright) automatic external defibrillator (AED) utilize solid state switches such as silicon controlled rectifiers (SCRs) and insulated gate bipolar transistors (IGBTs) connected in an H-bridge to produce a biphasic truncated exponential (BTE) defibrillation pulse. Such solid state switches require snubber circuits in series with the energy storage capacitor to control the rate of change of voltage or current through the switches to prevent switch damage as well as to prevent false triggering from transient energy. The snubber circuit in the Forerunner AED employs a 150 microHenry (uH) inductor. Similarly, in U.S. Pat. No. 5,824,017, xe2x80x9cH-Bridge Circuit For Generating A High-Energy Biphasic Waveform In An External Defibrillatorxe2x80x9d, issued Oct. 20, 1998, to Sullivan et al., a protective element having resistive and inductive properties is interposed between the energy storage capacitor and the H bridge. Sullivan et al teach that the protective element 27 is used to the limit the rate of change of voltage across, and current flow to, the SCR switches of the H bridge. However, snubber circuits, while designed to protect the switch components of the H-bridge, do not address the problem of limiting peak current to the patient across the range of patient impedances.
It would therefore be desirable to provide a defibrillator that delivers an impedance-compensated defibrillation pulse to the patient with limited peak currents.
A defibrillator capable of delivering a current-limited defibrillation pulse is provided. An energy storage circuit is charged to a high voltage by a high voltage charger circuit which receives its energy from a battery. The energy storage circuit is coupled across a high voltage switch such as an H-bridge for delivering a defibrillation pulse to the patient through a pair of electrodes. A controller operates to control the entire defibrillation process and detects shockable rhythms from the patient via an ECG front end.
The energy storage circuit consists of an energy storage capacitor, a series inductor, a shunt diode, and optionally a resistor in series with the inductor. The series inductor has an inductance value chosen to limit the peak current of the defibrillation pulse delivered to the patient for the lowest expected value of patient impedance. The inductance value is chosen as a function of the capacitance value and charge voltage of the energy storage capacitor. The series resistor may be added depending on the internal resistance of the series inductor. Alternatively, the series inductor may be modeled as an ideal inductor and the series resistor represents the effective series resistance (ESR) of the series inductor. The shunt diode is necessary to clamp the voltage generated by the energy stored in the series inductor because the defibrillation pulse is truncated by the high voltage switch. The waveform developed according to the present invention is a damped biphasic truncated (DBT) waveform which is distinct from the biphasic truncated exponential (BTE) waveform of the prior art.
The controller uses the current and voltage information supplied by the energy storage circuit to determine a patient dependent parameter. In the preferred embodiment, the patient dependent parameter is measured during the delivery of the defibrillation pulse. Alternatively, the patient dependent parameter may be measured before delivery of the defibrillation by the use of a low level signal or the delivery of a non-therapeutic pulse to the patient.
A patient dependent parameter is a measurement of time, voltage or current that is directly related to the patient impedance for the given combination of capacitance, inductance, and series resistance. This patient dependent parameter can be used by the controller to set the time of the first and second phases of the defibrillation pulse to control the amount of energy delivered to the patient. One such patient dependent parameter that can be determined in the case of the DBT defibrillation pulse is the measured time interval between the initial delivery of the defibrillation pulse to the time that the current or the voltage peaks. Other patient dependent parameters, such as the percentage voltage drop across the patient, percentage voltage drop across the energy storage capacitor, or measured time to reach a circuit charge delivery using a current integrator, may also be effectively used.
One feature of the present invention is to provide a defibrillator that delivers current limited defibrillation pulses.
A further feature of the present invention is to provide a defibrillator that delivers damped biphasic truncated (DBT) defibrillation pulses.
Another feature of the present invention is to provide an energy storage circuit capable of delivering current limited defibrillation pulses.
A further feature of the present invention is to provide a method of delivering damped biphasic truncated defibrillation pulses.
Other features, attainments, and advantages will become apparent to those skilled in the art upon a reading of the following description when taken in conjunction with the accompanying drawings.